Specialist, US Regulatory Affairs Operations (Part-Time)

Job Title: Specialist, US Regulatory Affairs Operations (Part-Time)
Duration: 18 Months
Location: St. Joseph, MO (64506) or Athens, GA (30601)
Schedule: 20 hours per week; Anywhere between 8 AM to 5 PM, Monday-Friday as scheduled.
Note the requirement to be in the office 2-3 days a week.
 
Duties:

• With minimum guidance, prepare high-quality US regulatory submissions required by local and federal agencies to maintain Company products on the market.
• With minimum guidance and supervision prepare regulatory submissions for activities such as labeling supplements, DERs, EPA monthly and aggregate reports, drug product listing, establishment registration, advertising and promotional materials, product import, pesticide state adverse event reporting, state licensing renewals, state product renewals, and tonnage reporting.
• With minimum guidance and supervision, contribute to the development and implementation of processes and work instructions.
• Understand and monitor regulatory trends; understand and implement regulations and guidance. Interact with the authorities in a professional manner.
• Responsive to government agencies for questions on submissions.
• With minimum guidance and supervision, support systems for product compliance and maintenance.

 
Skills:   

• *Note strong requirement for proficiency in MS Office applications and Adobe Acrobat
• General knowledge in relevant Regulatory Affairs areas.
• General knowledge and understanding of regulatory legislation and requirements for the maintenance of veterinary products
• General knowledge of the legal requirements for maintenance of veterinary medicinal products.
• Maintains compliance with respect to all requirements for assigned products.
• Ensures company interests are supported/maintained in negotiations with regulatory authorities resulting from requests and information received from regulatory authorities.
• Proficient in standard office technology, including Word, Excel, and Adobe Acrobat.
• Strong written and verbal communication skills
• Strong attention to detail
• Must exhibit good judgment, and ability to problem-solve issues in daily work
• Demonstrated ability to successfully collaborate in a global organization and manage a full workload.
• Able to meet stringent time and quality demands.
• Self-motivated with a high degree of initiative, commitment and persistence.
• Well developed organizational capabilities.
• Strong team player who is collaborative with the mission of the Client, but able to drive change.
• AI Competencies

 
Accountability: Taking ownership for decisions and actions.
Agility: Quickly acting with an open mind to face internal and external circumstances.
Intrapreneurship: Together with our customers, internal or external, creating innovative ideas to respond to changing needs.
 
Education:
Bachelor's degree and 1 year of relevant industry experience OR
Associate’s degree and 3 years of relevant industry experience OR
In lieu of a degree, 5 years of relevant industry experience including 1 year of related regulatory experience.
 
 
  

About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
 
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation. 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $54.00/hr.